BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 11641929 · Received April 9, 2021

    Report

    Report Number
    3011632150-2021-00012
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 5, 2020
    Report Date
    April 9, 2021
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850015
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF RESTENOSIS ARE LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE AND ARE KNOWN PATIENT EFFECTS OF PERIPHERAL STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELLING OF THE DEVICE. IF FURTHER INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D EUROPEAN POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2018 . AT INDEX PROCEDURE ((B)(6) 2018) THE PATIENT PRESENTED WITH A DE NOVO OCCLUSION OF THE SEGMENT INVOLVING THE SFA DISTAL THIRD IN THE LEFT LEG. ONE BIOMIMICS STENT (6.0 X 60MM) WAS IMPLANTED. ON (B)(6) 2020 A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THE EVENT WAS DESCRIBED AS "POSSIBLY RELATED" TO THE DEVICE AND "NOT RELATED" TO THE PROCEDURE. THIS EVENT IS REPORTED AS BEING NOT SERIOUS AND TARGET LESION RELATED. AT THE PATIENT'S 36-MONTH FOLLOW-UP ON (B)(6) 2021 , A RE-OCCLUSION IN THE SFA LEFT WAS IDENTIFIED WITH NO FLOW THROUGH THE BIOMIMICS STENT. THE OCCLUSION IS REPORTED AS STARTING AT THE BEGINNING OF THE SFA, WHERE ANOTHER STENT IS PLACED (UNKNOWN STENT), AND THE BIOMIMICS-3D STENT IS DISTAL. THERE WAS NO INTERVENTION CARRIED OUT ON THIS OCCLUSION BEFORE THE SUBJECT'S EXIT FROM THE STUDY ON (B)(6) 2021 . THE PATIENT OUTCOME IS DESCRIBED AS "CONTINUING". THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539803 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 412995 05391526850015

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other